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A Study of Icotrokinra for Moderately to Severely Active Crohn's Disease

This study is testing a drug called icotrokinra for people with moderately to severely active Crohn's disease (CD), a long-term condition causing severe inflammation of the intestines. The study aims to see how well icotrokinra works and if it is safe. You might be able to join if you are 18 or older and have a confirmed diagnosis of CD that is moderately to severely active. Researchers will look for improvements in your symptoms (clinical response) and whether your disease goes into remission (clinical remission) after 12 weeks. They will also check for healing in your intestines (endoscopic response). The study is comparing icotrokinra to a placebo (an inactive pill).

Study design
This study is an interventional trial planning to enroll 1092 participants. It is comparing the drug icotrokinra to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for this study are measured at Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07196722

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Recruiting
PHASE2Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~1,092 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:IcotrokinraPlacebo

At a glance

Recruiting sites
361 of 370 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Induction Study 1: Number of Participants with Clinical Response at Week 12
Measured over At Week 12
+4 more outcomes measured

Conditions

Crohn Disease

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Crohn Disease

Where it's being run

370 sites across 53 states
China35
Japan35
Brazil26
Poland26
France14
Germany12
South Korea12
California11

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2
Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments
A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy \[ADT\]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD- (ADT-inadequate responder \[IR\]) as defined in the protocol

Exclusion

Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention
Presence of a stoma or ostomy
Participants with presence of active fistulas may be included if there is no surgery needed
Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization

What this trial measures

  • Induction Study 1: Number of Participants with Clinical Response at Week 12At Week 12

    Clinical response is defined as a greater than or equal to (\>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

  • Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint)At Week 12

    Clinical remission is defined as CDAI score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

  • Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint)At Week 12

    Endoscopic response is defined as greater than (\>) 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

  • Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint)At Week 40

    Clinical remission is defined as CDAI score \< 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

  • Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)At Week 40

    Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.